This prospective multicentre study is planned to evaluate the next generation LAM assays and molecular diagnostics (POC and near POC) among people with presumptive Tuberculosis. The DriveDx4TB study aims to generate evidence needed to accelerate the introduction of three new classes of TB diagnostics, complemented by alternative sampling for use at primary healthcare and community settings. To this end, the study will leverage the accelerated innovation spurred by the COVID-19 pandemic, particularly the rapid development of swab-based sampling and molecular diagnostic (MDx) platforms.
Adult (≥18 years), with presumptive pulmonary TB i.e., self-reporting cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB*
Willing to provide written informed consent
Willing to provide sputum, and other samples (tongue swabs, urine)
Willingness to have a telephonic follow-up call 2-3 months post-enrolment
Participants currently on anti-TB treatment *
Any anti-TB treatment or antibiotics not specifically used for TB treatment, but which have anti-TB activity, e.g., fluoroquinolones given for respiratory tract infection within 60 days prior to enrolment
Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
Participants who have conditions or circumstances that preclude their participation, based on the judgement of the site investigator